Quality & Compliance Specialist

Job description

Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world and employs more than 4,000 professionals in Belgium. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.

At Discovery Sciences, the Core Business Services (CBS) group supports scientists with flawless, lean and effective operational business processes. The Quality and Compliance Management (QCM) team is part of CBS and ensures inspection readiness and compliance to regulatory requirements, J&J requirements, data integrity requirements (DDI) and best practices as defined by DS management.

Within the QCM team we are looking for a Quality & Compliance Specialist who will be coordinating these quality and compliance related activities by taking up below responsibilities. He/she will be reporting into the EU Quality & Compliance Manager.

Support the Preclinical Development and Safety organization to maintain its GLP Compliance level.

You will be coordinating a team of contractors that take care of the daily management of regulated documents such as SOP's, Work Instructions, Job Descriptions and Training Plans. You will support the department during government inspections and QA audits.

Take on a new quality oriented role to support Discovery Sciences in EU.

In this role, you will take on responsibilities to support the non-regulated groups at Discovery Sciences in Beerse with respect to quality related tasks such as managing training curricula in Summit to make sure applicable training courses are rolled out to the correct functional groups. You will build/maintain strong relationships with internal business partners (incl. QA) and external community by active participation in peer community via contributions at meetings, publications.

Member/Lead of different ad hoc projects.

You will take on project management responsibilities for ad hoc projects such as the GLP to non-GLP Transition effort on controlled documents or when compliance representation is required in IT system migrations.

Desired profile

Qualifications :

·  B Sc with +3 years of industry experience in quality and compliance activities;
·  Good knowledge of global regulatory guidelines related to Discovery Sciences (GxP, ISO, …);
·  Open mindset that enables maintaining the required compliance level and at the same time challenges the status quo and looks for process improvements;
·  Excellent written and verbal language skills in English and Dutch
·  Experience in quality related systems on Document and Training Management is a plus;
·  Strong interpersonal and communication skills as you must be able to work in a team environment and coordinate with the team to deliver high quality, accurate work within the agreed timelines.

What's in it for you…?

“Caring for the world, one person at a time…”

As an employee we consider you as our most valuable asset. We take your career seriously.

As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth.

Our benefits make sure we care for you and your family now and in the future.

Deze vacature is tot 24/7/2017 exclusief voorbehouden voor medewerkers wiens functie wegvalt door een organisatorische wijziging. Deze kandidaten worden met voorrang in het selectieproces opgenomen. De screening van andere kandidaten zal pas na deze periode gebeuren.